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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01242514




Registration number
NCT01242514
Ethics application status
Date submitted
10/11/2010
Date registered
17/11/2010
Date last updated
4/04/2014

Titles & IDs
Public title
Evaluation of Long-term Safety and Effectiveness of Fostamatinib in the Treatment of Rheumatoid Arthritis (RA)
Scientific title
(OSKIRA-X): A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium in the Treatment of Rheumatoid Arthritis
Secondary ID [1] 0 0
2010-020892-22
Secondary ID [2] 0 0
D4300C00005
Universal Trial Number (UTN)
Trial acronym
OSKIRA-X
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Fostamatinib
Treatment: Drugs - Fostamatinib
Treatment: Drugs - Fostamatinib

Experimental: A - Oral treatment

Experimental: B - Oral treatment

Experimental: C - Oral treatment


Treatment: Drugs: Fostamatinib
Fostamatinib 100mg twice daily

Treatment: Drugs: Fostamatinib
Fostamatinib 150mg once daily

Treatment: Drugs: Fostamatinib
Fostamatinib 100mg once daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Patients Who Had at Least 1 Adverse Event in Any Category
Timepoint [1] 0 0
Entry in extension to end of study (variable duration; maximum 109 weeks)
Secondary outcome [1] 0 0
Mean DAS28-CRP Score
Timepoint [1] 0 0
Weeks 0, 12, 24, 36 and 52
Secondary outcome [2] 0 0
Mean mTSS Score
Timepoint [2] 0 0
Weeks 0 and 52
Secondary outcome [3] 0 0
Mean HAQ-DI Score
Timepoint [3] 0 0
Weeks 0, 12, 24, 36 and 52

Eligibility
Key inclusion criteria
* Patients who have successfully completed a qualifying study (D4300C00001, D4300C00002, D4300C00003 or D4300C00004) with fostamatinib
* Patients who have participated in a qualifying study and who have been classified as non-responders due to pre-defined lack of efficacy at Week 12 (D4300C00001, D4300C00002, D4300C00003).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Premature withdrawal from the qualifying study (D4300C00001, D4300C00002, D4300C00003 and D4300C00004)
* Females who are pregnant or breast feeding
* Poorly controlled hypertension
* Significant liver function test abnormalities or physical symptoms of hepatotoxicity
* Significant infection
* Gastrointestinal intolerance
* Cancer

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2015
Actual
Sample size
Target
Accrual to date
Final
1917
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Research Site - Camperdown
Recruitment hospital [2] 0 0
Research Site - Southport
Recruitment hospital [3] 0 0
Research Site - Cairns
Recruitment postcode(s) [1] 0 0
- Camperdown
Recruitment postcode(s) [2] 0 0
- Southport
Recruitment postcode(s) [3] 0 0
- Cairns
Recruitment outside Australia
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Alabama
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the long term safety and tolerability of fostamatinib in patients with rheumatoid arthritis (RA).
Trial website
https://clinicaltrials.gov/study/NCT01242514
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Chris O'Brien, MD PhD
Address 0 0
AstraZeneca
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01242514